MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; DBD-MGW SHOULDER PACK

Catalog Number	DYNJ82595C
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility, "spinal needle inserted into patient's shoulder prior to incision by fellow.Fellow unable to removed stylet after insertion.Entire spinal needle was removed from shoulder and replaced." facility reports no serious injury related to this malfunction, patient only required a re-stick.No additional information at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the facility, "spinal needle inserted into patient's shoulder prior to incision by fellow.Fellow unable to removed stylet after insertion.Entire spinal needle was removed from shoulder and replaced.".

• Common Device Name: DBD-MGW SHOULDER PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; 3 lakes dr; northfield IL 60093
• Manufacturer Contact: alyssa reasner ; 3 lakes dr; northfield, IL 60093
• MDR Report Key: 23348742
• Report Number: 1423395-2025-00170
• Device Sequence Number: 9544918
• Product Code: OJH
• UDI-Device Identifier: 10195327465322
• UDI-Public: 10195327465322
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ82595C
• Device Lot Number: 25DBJ445
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/11/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Sex: Male